Home / Services / API Development Services

API Development

From early scale-up to clinical proof of concept

Symeres offers best-in-class chemistry solutions for early drug development. We provide route scouting, risk assessments, catalyst screens, solid-state chemistry, and early safety studies, to ensure that the route chosen for clinical supply will be robust, reliable, and ultimately scalable. We deliver your early clinical drug substance API (phase I/II).


Our API Development Services

Process Research and Development

To help to mitigate CMC risk when transitioning from research to development, we offer a range of services, such as route scouting, risk assessments, catalyst screens and early safety studies.

GMP Manufacturing

The processes developed at our facilities are optimized by our R&D chemists and adapted to the plant environment in close collaboration with our experienced process engineers.

GMP Starting Materials

Having control over the quality and delivery of the starting materials is essential in GMP manufacturing. Or non-GMP scale-up lab is dedicated to the synthesis of regulatory starting materials.

Solid State Chemistry and Pre-Formulation Research

We crystallize and formulate your compound for drug development to support clinical trials and IP protection.

ICH Stability Studies

We offer the possibility to perform long term as well as accelerated stability studies under standard conditions, according to ICH Q1A guidelines.

Quality Unit

Our GMP facilities are certified and FDA approved. Our QMS guarantees compliance to all required elements of GMP.

EHS Compliance

Our first priority is to guarantee the safety of the patients, our employees and the environment. Careful evaluation of all incoming materials and projects prevent exposure and (cross-)contamination.

Process Research and Development

To help to mitigate CMC risk when transitioning from research to development, we offer a range of services, such as route scouting, risk assessments, catalyst screens and early safety studies.

GMP Manufacturing

The processes developed at our facilities are optimized by our R&D chemists and adapted to the plant environment in close collaboration with our experienced process engineers.

GMP Starting Materials

Having control over the quality and delivery of the starting materials is essential in GMP manufacturing. Or non-GMP scale-up lab is dedicated to the synthesis of regulatory starting materials.

Solid State Chemistry and Pre-Formulation Research

We crystallize and formulate your compound for drug development to support clinical trials and IP protection.

ICH Stability Studies

We offer the possibility to perform long term as well as accelerated stability studies under standard conditions, according to ICH Q1A guidelines.

Quality Unit

Our GMP facilities are certified and FDA approved. Our QMS guarantees compliance to all required elements of GMP.

EHS Compliance

Our first priority is to guarantee the safety of the patients, our employees and the environment. Careful evaluation of all incoming materials and projects prevent exposure and (cross-)contamination.

Scroll to top